- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Development Operations or Senior Director, Clinical Operations on plans for successful implementation of studies . Responsible for management of ... best-in-class procedures and SOP's related to clinical study oversight and execution.Work with TMF Operations ...appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies… more
- Merck & Co. (North Wales, PA)
- …country teams, vendors, committees, investigators, site personnel, etc.) in support of clinical study objectives.- Accountable for managing any study ... innovative medicine.Accountable for the operational planning, feasibility, and execution of a clinical protocol.- May lead team in key study planning,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study ... goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… more
- Merck & Co. (Rahway, NJ)
- …the further study of marketed compounds.In executing these duties, the Senior Director may:Supervise the activities of Clinical Scientists in the execution ... support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint… more
- Merck & Co. (Rahway, NJ)
- …Activities may include, but are not limited to: Creates and develops clinical databases and data transfer files according to written specifications. Ensures ... adherence to clinical database standards, SOPs and Process Guidelines. Leads and... Data Management System (CDMS). Interface with members of study teams, including external CROs/Vendors where applicable, to integrate… more
- Insmed Incorporated (Bridgewater, NJ)
- … Clinical Operations objectives by providing operational support to the clinical study team (CST) with the responsibility to manage multiple clinical ... regulations, etc.Provides operational support for the Clinical Operations team with heavy focus on study ...third‐party vendors to ensure successful and quality execution of studies , and builds strong working relationships to create strong… more
- Merck & Co. (Rahway, NJ)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... may:Supervise the activities of Clinical Scientists in the execution of clinical studies ;Work closely with a cross-functional group of experts in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Global Development organization this is a key new role to lead the Clinical Operations function across our Boston, MA and Princeton, NJ campuses through ... both direct leadership of the core Clinical Operations function, as well as ensuring...and clinical partners to ensure delivery of clinical objectives within established timelines and budget Senior… more
- Merck & Co. (North Wales, PA)
- …program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.- ... to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.-Is responsible for planning and ensuring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …up, model the way and enable the team to act.Provides medical leadership toGMA clinical operations teams as part of evidence generation forums and study ... research areas centered around rare diseases and immune disorders.Summary The Senior Director, Global Oncology Medical Affairs is responsible for developing the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides… more
- Eisai, Inc (NJ)
- …profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the outsourcing ... of clinical services to Clinical Research Organizations (CROs)...including functional services.Accountable for vendor management; providing guidance to study teams on vendor selection and management options in… more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations . Essential Functions Work with ... of the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.Knowledge of regulatory… more
- Merck & Co. (Rahway, NJ)
- …assigned to a development project as neededLead biostatistics in early or late clinical development planning to ensure that study designs are consistent with ... program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.-… more
- Merck & Co. (Rahway, NJ)
- …trial level. Primary activities include, but are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager ... Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management… more
- Merck & Co. (Rahway, NJ)
- …submission strategies.Ensures the statistical designs and analysis methods utilized in clinical studies are scientifically sound and meet worldwide regulatory ... marketing needs.Perform comprehensive review of protocols, statistical analysis plans, clinical study reports, and submission documents to...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers will be responsible for driving execution of ... and regionsServes as an impactful member of Product Development Team sub-teams ( Clinical , Value Evidence, Commercial, Publications and Label) and Global Human Health… more
- Merck & Co. (Rahway, NJ)
- …standards development teamsThe Vocabulary Specialist maintains knowledge of new technologies, clinical study data standards, regulatory requirements emerging in ... Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries...across GCDS by actively communicating and proactively sharing informationSupport senior /leadership roles, in areas of observed competence, to enhance… more
- Merck & Co. (Rahway, NJ)
- …registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to ... approaches to develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and… more
